Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress
A Randomized Controlled Trial of CBT for Insomnia in Patients With PTSD and Depression
2 other identifiers
interventional
110
1 country
1
Brief Summary
The primary purpose of this study is to test whether and how cognitive-behavioral therapy for insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms. The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to assess the role of neurobiological processes and sleep architecture in mediating treatment outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 27, 2017
August 1, 2016
4.1 years
December 4, 2012
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD (intensity and frequency for each symptom, and remission)
The Clinician Administered PTSD Scale (CAPS)will be used as our primary PTSD outcome measure.
20 weeks
Secondary Outcomes (2)
Insomnia severity
20 weeks
Depression
20 weeks
Other Outcomes (3)
Sleep
7 weeks.
Salivary Cortisol
7 weeks
Inflammatory cytokine levels (IL-6)
7 weeks
Study Arms (2)
Control
ACTIVE COMPARATORControl (brief check-in calls) and Cognitive Processing Therapy (12 individual weekly sessions)
Cognitive Behavioral Therapy
EXPERIMENTALCognitive Behavioral Therapy for Insomnia (4 individual therapy sessions over 5 weeks) and Cognitive Processing Therapy (12 individual weekly sessions)
Interventions
Cognitive Behavioral Therapy for Insomnia(4 individual therapy sessions over 5 weeks) will consist of a standard, structured, multi-component CBT intervention (sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention) Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions
Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions.
Eligibility Criteria
You may qualify if:
- must be English-speaking
- age 18-64 years old
- with exposure to trauma from interpersonal violence in the past year
- meet diagnostic criteria for full or subthreshold PTSD
- meet diagnostic criteria for MDD
- meet criteria for Insomnia Disorder
You may not qualify if:
- untreated sleep disorders other than insomnia or nightmares
- dementia or cognitive impairment
- history of schizophrenia or bipolar I disorder
- current suicidality
- health conditions with immunological components or taking immunosuppressive therapies
- active alcohol dependence
- medication use including antipsychotics, opiate analgesics, and sleep medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (1)
Pigeon WR, Heffner KL, Crean H, Gallegos AM, Walsh P, Seehuus M, Cerulli C. Responding to the need for sleep among survivors of interpersonal violence: A randomized controlled trial of a cognitive-behavioral insomnia intervention followed by PTSD treatment. Contemp Clin Trials. 2015 Nov;45(Pt B):252-260. doi: 10.1016/j.cct.2015.08.019. Epub 2015 Sep 4.
PMID: 26343743DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilfred R. Pigeon, Ph.D.
University of Rochester
- PRINCIPAL INVESTIGATOR
Kathi L. Heffner, Ph.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 6, 2012
Study Start
January 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 27, 2017
Record last verified: 2016-08